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Catalog Number RD3-8-150
Device Problems Material Fragmentation (1261); Material Rupture (1546); Material Separation (1562); Device Or Device Fragments Location Unknown (2590)
Patient Problems Intimal Dissection (1333); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Event Date 02/13/2018
Event Type  Injury  
Manufacturer Narrative
The actual device concerned was returned and investigated: the returned product consisted of a catheter from the broken edge of the balloon portion till the proximal end (the hub-parts) and a fragment of the distal portion of the inner tube (the guidewire lumen) of about 24cm long. The distal portion of the broken balloon with the distal tip was not included in the returned product. The fragmented inner tube was sheared off at the connecting part to the distal tip and about 15mm distal of the guidewire port, that exhibited trace of significant elongation and bellows structure. The inner tube remained in the catheter shaft exhibited similarly trace of elongation with bellows structure. The balloon was cut in the middle. The effective length of this balloon is 8mm, and accordingly the missing portion (probably remained in the patient's vessel) is estimated about 10mm including the 4mm long distal tip. The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test, the shaft-pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan. No nonconformity or abnormality in the manufacturing processes of the device concerned was found. Probable cause(s) and our comment: the balloon should have been injured with a sharp edge of the calcified lesion or another device(s) concomitantly used and was ruptured when inflated. Then, the balloon and the inner tube were broken apart when the device was forcibly pulled back, while the ruptured balloon portion was trapped in the lesion. It was reported that a vascular dissection occurred while the dr. Tried to recover the broken fragment of the device by using a snare device. However, this attempt seemed unsuccessful and the distal portion of the balloon with the distal tip remained in the patient's vessel. No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the event reported was caused by not any defect of the device but the device handling-issues.
Event Description
Although the concerned device, subject to this reported event "raiden3", an rx-type ptca balloon dilatation catheter compatible with 0. 014" guidewire (gw), is not distributed in the us, we intend to report this case as the event occurred on one of the similar devices for "rx nc takeru ptca balloon dilatation catheter" distributed in the us under 510(k) # k170941. After pre-dilating the lcx periphery by an another semi-compliant balloon dilatation catheter, the raiden3 was employed for a post-dilation of the lesion. The balloon of the raiden3 ruptured when inflated in the lesion, although the pressure applied was below the rated burst pressure (rbp). The dr. Tried to retrieve the raiden3, but the ruptured balloon portion was trapped in the lesion, and the distal portion was broken to remain in the lesion when it was pulled out of the patient's vessel. While trying to recover the fragment remained in the lesion by using a snare device, a vascular dissection occurred. The dr. Recognized some of distal portion of the raiden3 was missing in the device removed out of the patient, but the dr. Could not identify where the missing portion was in the patient. The dr. Immediately decided to conduct a cabg to bailout the incomplete ptca. The cabg was successful and, since the patient's condition was stable with no aftereffect, the dr. Decide to remain the fragment of the balloon possibly remained in the lesion as it would be.
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Manufacturer (Section D)
nakanoshima, kita-ku
osaka, osaka 530-8 288
JA 530-8288
Manufacturer Contact
kazuhiko inoue
nakanoshima, kita-ku
osaka, osaka 530-8-288
JA   530-8288
MDR Report Key7330004
MDR Text Key102069352
Report Number3002808904-2018-00001
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberRD3-8-150
Device Lot NumberSP117122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2018 Patient Sequence Number: 1